CN101632647A - Preparation method for compound preparation comprising aspirin and alkaline drugs - Google Patents
Preparation method for compound preparation comprising aspirin and alkaline drugs Download PDFInfo
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- CN101632647A CN101632647A CN200810132163A CN200810132163A CN101632647A CN 101632647 A CN101632647 A CN 101632647A CN 200810132163 A CN200810132163 A CN 200810132163A CN 200810132163 A CN200810132163 A CN 200810132163A CN 101632647 A CN101632647 A CN 101632647A
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Abstract
The invention relates to a preparation method for a compound preparation comprising aspirin and alkaline drugs. The main technical points of the invention are that: the aspirin is prepared by dry granulation; the granulated aspirin and granules prepared by alkaline medicaments are pressed into double-layer tablets by a double-layer tablet machine; and then the double-layer tablets are coated. The aspirin is not stable and is easily hydrolyzed to generate free salicylic acid, so the dry granulation is adopted; the prepared double-layer tablets can prevent that the alkaline drugs quicken hydrolyzation of the aspirin; and the prepared coated tablets can be moistureproof, prevent that double layers of the double-layer tablets from being separated or expanded, and guarantee quality and stablity of products.
Description
Technical field
The present invention relates to the compound preparation that a kind of aspirin and alkalescent medicine are made, adopt the preparation method of double-layer coatings.
Background technology
That the compound preparation that heavy dose of aspirin and alkalescent medicine are formed has is analgesic, analgesia, antiinflammatory action, and low-dosage aspirin has the inhibition platelet aggregation with the compound preparation that alkalescent medicine is formed, in advance the effect of preventing thrombosis generation.Such compound preparation has tangible advantage: can lower the pessimal stimulation of aspirin to stomach on the one hand, significantly reduce the incidence rate of gastrointestinal mucosa erosion and ulcer; Also can increase its trap on the other hand, alkalescent medicine can make rapid gastric emptying, thereby makes aspirin enter main absorption site-small intestinal rapidly.Aspirin is because the blocking-up thromboxane A
2Synthetic, the damage gastric mucosa causes that gastric mucosa is slight rotten to the corn and form ulcer, hemorrhage, perforation, and therefore taking aspirin in a single day forms ulcer, takes place more serious hemorrhage easily.Alkalescent medicine is antiacid and gastric mucosa protectant, has astriction, can form protecting film on the ulcer surface, promotes the healing of ulcer surface; Also can in and gastric acid, alleviate flatulence etc.Therefore, the compound preparation of being made up of aspirin and alkalescent medicine has the stronger market competitiveness.
Aspirin (aspirin), to damp and hot equal instability, facile hydrolysis produces free salicylic acid, particularly easily produces interaction with alkalescent medicine mixing granulation tabletting, influences stability of drug.So the compound preparation that aspirin and alkalescent medicine are formed adopts respectively and granulates, and is pressed into double-layer tablet, then with double-layer tablet bag film-coat.The aspirin layer adopts dry granulation, avoids damp and hot influence to aspirin stability.The bag film-coat can be avoided the influence of extraneous moisture to aspirin stability, prevents the layering that the double-layer tablet imbibition causes simultaneously.At present such preparation often adopts tabletting again behind the aspirin coating, but because of easily adhesion after the granule coating, is difficult to and other auxiliary materials and mixing in the pressing process.The present invention adopts easy-operating preparation process, guarantees the quality of product from three links, but preparation technology's industrialization.
Summary of the invention
Technical essential of the present invention is first with the aspirin dry granulation, has avoided the influence to aspirin stability of moisture content and bake out temperature; Adopt the compacting double-layer tablet, can avoid alkalescent medicine to quicken the degraded of aspirin; Double-layer tablet is carried out coating can avoid the influence of extraneous factor the double-layer tablet stability of aspirin and alkalescent medicine composition.
The problem to be solved in the present invention is that the stability and the two-layer of double-layer tablet of aspirin separates or expansible physical stability problem.The aspirin stability problem is by aspirin being adopted dry granulation, make double-layer tablet with alkalescent medicine, carries out at last that the double-layer tablet coating solves.Also solved problem such as expand after the easy layering of double-layer tablet and the easy moisture absorption by coating in addition.
The present invention be achieved in that (1) with the aspirin raw material add filler, stabilizing agent is pressed into granule through the dry granulation machine, grain diameter is sneaked into lubricant before the tabletting between 10 order to 20 orders; (2) alkalescent medicine is added filler, add binding agent system granule again, sneak into lubricant before the tabletting; (3) two-layer granule is mixed after the bi-layer tablet press tabletting; (4) with the double-layer tablet bag film-coat that suppresses.
The percentage by weight of each composition is (1) aspirin 80～95 in each layer of the present invention, filler 5～15, stabilizing agent 0.5～1.5, disintegrating agent 1～5, lubricant 1～5; (2) alkalescent medicine 20～70, filler 15～45, lubricant 1～5; (3) film coating liquid: hydroxypropyl methylcellulose 60～90, ethyl cellulose 10～30, Polyethylene Glycol 1～5, titanium dioxide 1～5,90% ethanol 60～80.
The specific embodiment
Further specify the present invention by embodiment, but protection scope of the present invention is not limited in these embodiment.
The embodiment of the invention 1～embodiment 4 (preparation of the compound preparation that aspirin and alkalescent medicine are formed)
The embodiment of the invention 1
Aspirin layer (10000)
Aspirin 3300g
Tartaric acid 33g
Carboxymethyl starch sodium 80g
Silicon dioxide 50g
Cushion (10000)
Hydrotalcite 1000g
Amylum pregelatinisatum 500g
The 90% alcoholic solution 1500ml of 10%PVPk30
Silica 1 5g
Coating solution (10000 amounts)
Hydroxypropyl emthylcellulose 150g
Ethyl cellulose 30g
Polyethylene Glycol 50g
Titanium dioxide 20g
85% ethanol 3000ml
Method for making: the aspirin of recipe quantity and tartaric acid are mixed, are pressed into 10 purpose granules through the dry granulation machine, again with carboxymethyl starch sodium and silicon dioxide mixing as aspirin layer granule; With the 90% alcoholic solution system soft material of 10%PVPk30, granulate through the screen cloth of 18# behind hydrotalcite and the amylum pregelatinisatum mixing, wet granular gets the cushion granule through 80 ℃ of dryings; Two-layer granule is pressed into double-layer tablet through bi-layer tablet press; With double-layer tablet bag film-coat promptly, coating weightening finish 3%-4%.This product has analgesic, analgesia, antiinflammatory action.
The embodiment of the invention 2
Aspirin layer (10000)
Aspirin 3000g
Starch 495g
Tartaric acid 33g
Silicon dioxide 50g
Cushion (10000)
Hydrotalcite 1000g
Starch 500g
The 90% alcoholic solution 1500ml of 10%PVPk30
Silica 1 5g
Coating solution (10000 amounts)
Hydroxypropyl emthylcellulose 150g
Ethyl cellulose 30g
Polyethylene Glycol 50g
Titanium dioxide 20g
85% ethanol 3000ml
Method for making: the aspirin of recipe quantity and starch, tartaric acid are mixed, be pressed into 10 purpose granules, add the silicon dioxide mixing as aspirin granule through the dry granulation machine; With the 90% alcoholic solution system soft material of 10%PVPk30, granulate through the screen cloth of 18# behind hydrotalcite and the starch mixing, wet granular must be done granule through 80 ℃ of dryings; Two-layer granule is pressed into double-layer tablet through bi-layer tablet press; With double-layer tablet promptly, coating weightening finish 3%-4% with above-mentioned coating solution bag film-coat.This product has analgesic, analgesia, antiinflammatory action.
The embodiment of the invention 3
Aspirin layer (10000)
Aspirin 5000g
Amylum pregelatinisatum 430g
Citric acid 33g
Low-substituted hydroxypropyl cellulose 65g
Sodium lauryl sulphate 50g
Cushion (10000)
Calcium carbonate 450g
Magnesium oxide 550g
Lactose 500g
The 90% alcoholic solution 1500ml of 10%PVPk30
Sodium lauryl sulphate 15g
Coating solution (10000 amounts)
Hydroxypropyl emthylcellulose 250g
Ethyl cellulose 60g
Glycerol 80g
Titanium dioxide 20g
85% ethanol 5000ml
Method for making: the aspirin of recipe quantity and amylum pregelatinisatum, tartaric acid are mixed, be pressed into 10 purpose granules, add low substituted hydroxy-propyl methylcellulose and sodium lauryl sulphate mix homogeneously again, as aspirin layer granule through the dry granulation machine; With the 90% alcoholic solution system soft material of 10%PVPk30, granulate through the screen cloth of 18# behind calcium carbonate and magnesium oxide and the starch mixing, wet granular must be done granule through 80 ℃ of dryings; Two-layer granule is pressed into double-layer tablet through bi-layer tablet press; With double-layer tablet promptly, coating weightening finish 3%-4% with above-mentioned coating solution bag film-coat.This product has analgesic, analgesia, antiinflammatory action.
The embodiment of the invention 4
Aspirin layer (10000)
Aspirin 810g
Amylum pregelatinisatum 430g
Tartaric acid 33g
Low-substituted hydroxypropyl cellulose 65g
Sodium lauryl sulphate 50g
Cushion (10000)
Dihydroxyaluminum aminoacetate 110g
Heavy Magnesium Carbonate 220g
Lactose 500g
The 90% alcoholic solution 800ml of 10%PVPk30
Sodium lauryl sulphate 15g
Coating solution (10000 amounts)
Hydroxypropyl emthylcellulose 150g
Ethyl cellulose 30g
Glycerol 50g
Pulvis Talci 20g
85% ethanol 3000ml
Method for making: the aspirin of recipe quantity and amylum pregelatinisatum, tartaric acid are mixed, be pressed into 10 purpose granules, add low substituted hydroxy-propyl methylcellulose and sodium lauryl sulphate mix homogeneously again, as aspirin layer granule through the dry granulation machine; With the 90% alcoholic solution system soft material of 10%PVPk30, granulate through the screen cloth of 18# behind dihydroxyaluminum aminoacetate and Heavy Magnesium Carbonate and the starch mixing, wet granular must be done granule through 80 ℃ of dryings; Two-layer granule is pressed into double-layer tablet through bi-layer tablet press; With double-layer tablet promptly, coating weightening finish 3%-4% with above-mentioned coating solution bag film-coat.This product is used for stability and unstable angina, myocardial infarction, ischemic cerebrovascular disorders etc.
The embodiment of the invention 5～embodiment 7 (making the study on the stability of product)
Main investigation project and method, limit:
Appearance character: range estimation. in vain with double-layer coating plate, score layer not.
Assay: ultraviolet-visible spectra photometric method Chinese Pharmacopoeia method.Limits (95.0%～105.0%)
Aspirin dissolution: ultraviolet-visible spectra photometric method (Chinese Pharmacopoeia method version official method in 2005).Limits is not less than 80%
Free salicylic acid: high performance liquid chromatography (Chinese Pharmacopoeia method version official method in 2005).Limits must not cross 1.0%
50 months sample leading indicators of embodiment quality investigation
0 month leading indicator assay of table 1 double-layer coating plate
| Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | |
| Appearance character | The white double-layer coating plate does not have layering | The white double-layer coating plate does not have layering | The white double-layer coating plate does not have layering | The white double-layer coating plate does not have layering |
| Aspirin content (%) | ??99.3 | ??101.2 | ??99.5 | ??99.7 |
| Aspirin stripping (%) | ??98.5 | ??99.2 | ??98.9 | ??99.0 |
| Free salicylic acid (%) | ??0.15 | ??0.13 | ??0.12 | ??0.09 |
Embodiment 6 accelerated test sample in June quality are investigated (RH75 ± 5%, 40 ± 2 ℃)
Table 2 double-layer coating plate quickens leading indicator assay in June
| Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | |
| Appearance character | The white double-layer coating plate does not have layering | The white double-layer coating plate does not have layering | The white double-layer coating plate does not have layering | The white double-layer coating plate does not have layering |
| Aspirin content (%) | ??99.1 | ??100.5 | ??98.9 | ??99.3 |
| Aspirin stripping (%) | ??98.2 | ??98.5 | ??97.8 | ??98.6 |
| The free salicylic acid amount | ??0.45 | ??0.58 | ??0.51 | ??0.42 |
Embodiment 7 long term test sample in June quality are investigated (RH60 ± 10%, 25 ± 2 ℃)
Table 3 double-layer coating plate long term test leading indicator in June assay
| Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | |
| Appearance character | The white double-layer coating plate does not have layering | The white double-layer coating plate does not have layering | The white double-layer coating plate does not have layering | The white double-layer coating plate does not have layering |
| Aspirin content (%) | ??99.0 | ??100.1 | ??99.1 | ??99.3 |
| Aspirin stripping (%) | ??98.1 | ??98.9 | ??98.6 | ??99.1 |
| The free salicylic acid amount | ??0.21 | ??0.23 | ??0.19 | ??0.15 |
By the investigation result of experimental example as seen, adopt the sample of method preparation of the present invention, steady quality, 6 months result of accelerated test 6 months and long term test and new system sample variation are little, have reached the invention expected effect.
Claims (7)
1, a kind of preparation method that contains the compound preparation of aspirin and alkalescent medicine composition.It is characterized in that:
(1) the two-layer cushion that is respectively aspirin layer and alkalescent medicine composition in the double-layer tablet;
(2) the aspirin layer in the double-layer tablet adopts dry granulation;
(3) two-layer granule is pressed into double-layer tablet through bi-layer tablet press;
(4) with double-layer tablet bag film-coat.
2, the described preparation method of claim 1, the cushion in the double-layer tablet is formed alone or in combination by hydrotalcite, dihydroxyaluminum aminoacetate, Heavy Magnesium Carbonate, calcium carbonate, magnesium oxide.
3, the described preparation method of claim 1, the aspirin layer adopts dry granulation, and aspirin or aspirin are added diluent, stabilizing agent through dry granulation mechanism grain, adds disintegrating agent and lubricant again.
4, the described preparation method of claim 3, diluent, stabilizing agent, disintegrating agent, lubricant that the aspirin layer adds are pharmaceutically acceptable diluent, stabilizing agent, disintegrating agent, lubricant.Diluent preferred starch, amylum pregelatinisatum, lactose; The preferred tartaric acid of stabilizing agent, citric acid; The preferred carboxymethyl starch sodium of disintegrating agent, low substituted hydroxy-propyl methylcellulose; The preferred silicon dioxide of lubricant, sodium lauryl sulphate.The adding total amount of adjuvant is about 5%～15%.The adjuvant that cushion adds is an acceptable accessories, preferred starch, arabic gum, and lactose, microcrystalline Cellulose, mannitol, sorbitol, silicon dioxide, sodium lauryl sulphate, amount ranges is 10%～40%.
5, the described preparation method of claim 1 is with the bi-layer tablet press compacting, after wherein the aspirin layer carries out precompressed earlier, adds the compression moulding of cushion secondary again.The hardness of double-layer tablet is between 8kg-13kg.
6, right has film former with asking 1 described preparation method in the composition of film coating liquid, solvent, plasticizer, covering agent.
7, the described film former of claim 6 is a hydroxypropyl emthylcellulose, and ethyl cellulose reaches other pharmaceutically acceptable thin film dress material material, is preferably the mixing coating material of hydroxypropyl emthylcellulose and ethyl cellulose, and its concentration is 3～10%; Solvent is 50%～90% pure water mixed solvent, preferred concentration 80%～90%; Plasticizer is a Polyethylene Glycol, glycerol, and diethyl phthalate, preferred Polyethylene Glycol increases the consumption 0.1%～3% against agent, and covering agent is preferably titanium oxide, Pulvis Talci, consumption 0.1～2%.
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| Application Number | Priority Date | Filing Date | Title |
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| CN200810132163A CN101632647A (en) | 2008-07-21 | 2008-07-21 | Preparation method for compound preparation comprising aspirin and alkaline drugs |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200810132163A CN101632647A (en) | 2008-07-21 | 2008-07-21 | Preparation method for compound preparation comprising aspirin and alkaline drugs |
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Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101904865A (en) * | 2010-07-23 | 2010-12-08 | 湖北丽益医药科技有限公司 | Hydrotalcite dispersible tablet and preparation method thereof |
| CN102198147A (en) * | 2010-03-24 | 2011-09-28 | 济南瑞安药业发展有限公司 | New preparation method for aspirin-containing compound preparation |
| CN104434957A (en) * | 2014-12-16 | 2015-03-25 | 天圣制药集团股份有限公司 | Method for preparing compound aspirin double-layer tablet |
| CN104434932A (en) * | 2014-12-18 | 2015-03-25 | 成都苑东药业有限公司 | Pharmaceutical composition of clopidogrel hydrogen sulfate and acetylsalicylic acid tablet and preparation method thereof |
| CN104523710A (en) * | 2014-12-30 | 2015-04-22 | 石药集团欧意药业有限公司 | Compound clopidogrel hydrogen sulphate and aspirin double-layer tablet and preparation method thereof |
| CN106727380A (en) * | 2016-12-28 | 2017-05-31 | 西藏昌都金方药业有限公司 | A kind of aluminium piece（Ⅱ）And its preparation technology |
| CN109789152A (en) * | 2016-06-28 | 2019-05-21 | 阿萨德股份有限公司 | Two-component composition |
| CN112675139A (en) * | 2021-01-11 | 2021-04-20 | 重庆康刻尔制药股份有限公司 | Aspirin carvedilol tablet and preparation method thereof |
| CN113230221A (en) * | 2021-04-06 | 2021-08-10 | 北京诚济制药股份有限公司 | Aluminum magnesium pilin tablet (II) |
| CN116059385A (en) * | 2023-03-13 | 2023-05-05 | 山东中健康桥制药有限公司 | Aluminum magnesium pilin pharmaceutical composition and preparation method thereof |
| US11844806B2 (en) | 2017-12-22 | 2023-12-19 | Asamedic As | Compositions comprising acetylsalicylic acid and a phosphate salt |
| US11850253B2 (en) | 2017-12-22 | 2023-12-26 | Asamedic As | Two component compositions |
-
2008
- 2008-07-21 CN CN200810132163A patent/CN101632647A/en active Pending
Cited By (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102198147A (en) * | 2010-03-24 | 2011-09-28 | 济南瑞安药业发展有限公司 | New preparation method for aspirin-containing compound preparation |
| CN101904865A (en) * | 2010-07-23 | 2010-12-08 | 湖北丽益医药科技有限公司 | Hydrotalcite dispersible tablet and preparation method thereof |
| CN104434957A (en) * | 2014-12-16 | 2015-03-25 | 天圣制药集团股份有限公司 | Method for preparing compound aspirin double-layer tablet |
| CN104434957B (en) * | 2014-12-16 | 2019-07-09 | 天圣制药集团股份有限公司 | A method of preparing magnalium department double-layer tablets |
| CN104434932A (en) * | 2014-12-18 | 2015-03-25 | 成都苑东药业有限公司 | Pharmaceutical composition of clopidogrel hydrogen sulfate and acetylsalicylic acid tablet and preparation method thereof |
| CN104434932B (en) * | 2014-12-18 | 2017-05-24 | 成都苑东生物制药股份有限公司 | Pharmaceutical composition of clopidogrel hydrogen sulfate and acetylsalicylic acid tablet and preparation method thereof |
| CN104523710A (en) * | 2014-12-30 | 2015-04-22 | 石药集团欧意药业有限公司 | Compound clopidogrel hydrogen sulphate and aspirin double-layer tablet and preparation method thereof |
| CN104523710B (en) * | 2014-12-30 | 2018-05-25 | 石药集团欧意药业有限公司 | A kind of bisulfate clopidogrel aspirin Composite Double synusia and preparation method thereof |
| CN109789152A (en) * | 2016-06-28 | 2019-05-21 | 阿萨德股份有限公司 | Two-component composition |
| US11369581B2 (en) | 2016-06-28 | 2022-06-28 | Asamedic As | Two component composition |
| US11918554B2 (en) | 2016-06-28 | 2024-03-05 | Asamedic As | Two-component composition |
| CN106727380A (en) * | 2016-12-28 | 2017-05-31 | 西藏昌都金方药业有限公司 | A kind of aluminium piece（Ⅱ）And its preparation technology |
| US11844806B2 (en) | 2017-12-22 | 2023-12-19 | Asamedic As | Compositions comprising acetylsalicylic acid and a phosphate salt |
| US11850253B2 (en) | 2017-12-22 | 2023-12-26 | Asamedic As | Two component compositions |
| CN112675139A (en) * | 2021-01-11 | 2021-04-20 | 重庆康刻尔制药股份有限公司 | Aspirin carvedilol tablet and preparation method thereof |
| CN113230221A (en) * | 2021-04-06 | 2021-08-10 | 北京诚济制药股份有限公司 | Aluminum magnesium pilin tablet (II) |
| CN116059385A (en) * | 2023-03-13 | 2023-05-05 | 山东中健康桥制药有限公司 | Aluminum magnesium pilin pharmaceutical composition and preparation method thereof |
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Application publication date: 20100127 |